Cascade Technologies, Corp. (OTCBB: CSDT) announced today that, in response to significant recent attention to the Food and Drug Administration (FDA) panel evaluation of Mela Sciences’ (Nasdaq: MELA) MelaFindTM device, the company has received a number of inquiries about its similar instrument. "We believe," said Dr. Daniel Farkas, Chairman and CEO, "that it is useful to reaffirm our position on the non-invasive detection of melanoma by our SkinSpectTM device under development."
Spectral Molecular Imaging, Inc. (SMI), a wholly owned subsidiary of Cascade Technologies, is pursuing the development and subsequent validation of a medical imaging device – SkinSpectTM – that is geared towards enabling clinicians to achieve reliable, early detection of skin cancers, with emphasis on melanoma, the deadliest form of these cancers: in the US 121,840 new cases of melanoma were diagnosed in 2009, and one person dies of melanoma every hour. The severity and fast growth of this problem calls for quality solutions, involving the best tools that modern technology affords.
In expressing the company’s position Dr. Farkas, explained that: “We all want the very best for the patients, and the methods we develop have to be infused with that objective. Before balancing any cost/benefit considerations, we have to ensure that what we build is both absolutely safe and sufficiently advanced to constitute a significant improvement over current standards. While we are pleased to see that the FDA panel evaluating MelaFindTM – which is a 10-wavelengths imaging device – estimated (narrowly) that the need to save additional lives outweighs the remaining concerns about performance, we believe that we can contribute something additional to this field.
Our enabling technology is true spectral imaging that includes the visible and part of the infrared range, and samples it with 50 different wavelengths. It is known as band-sequential hyperspectral imaging. This core capability was originally developed for satellite reconnaissance, and thus optimized for finding difficult-to-discern objects, barely different from their surroundings. This is very similar to the challenge of early disease, arising out of a normal area and imaged in a reflectance mode. Together with some additional features of our recently completed SkinSpectTM prototype, such as polarization control (that obviates the need for a contact fluid) and autofluorescence, we anticipate that detection of distinguishing features of melanoma will be enhanced. Both safety and performance will, of course, need to be assessed quantitatively in carefully planned testing on patients, after consultations with the FDA. We forsee learning from the years of experience accumulated in this field, including in the large trial conducted by Mela Sciences. We further expect both high sensitivity and specificity in our trials, based on all our previously conducted biomedical studies utilizing hyperspectral imaging (encompassing cytopathology, histopathology, fresh unlabeled ex-vivo specimens, in vivo preclinical and pilot clinicals, on patients), all of which yielded simultaneous detection sensitivities and specificities of 92-100%.
High sensitivity is clearly important for saving lives. High specificity on the other hand contributes to reducing the number of unnecessary biopsies, thus saving money for patients and the medical system. We maintain our focus on achieving both. We believe that new advanced products such as our SkinSpectTM device, when developed, validate the usefulness of quantitative, high-tech approaches to the difficult challenges of the clinical world, going far beyond what human vision can accomplish.”
About Spectral Molecular Imaging
Spectral Molecular Imaging, Inc., a wholly-owned subsidiary of Cascade Technologies Corp., is a development-stage medical imaging device company, applying its proprietary hyperspectral-optical imaging technology, originally developed for satellite reconnaissance, to advance the early and accurate diagnoses of cancer and precancerous conditions. SMI is developing non-invasive imaging systems using its patented technology and other proprietary knowhow for improved clinical diagnostics, primarily in the field of cancer pathology. SMI’s devices utilize high-resolution imaging, identification, and analysis of certain molecular, cellular, and tissue features via patented spectral-imaging approaches. We expect to provide services related to our primary products, including software modules and maintenance services, and to develop optical diagnostic products that operate in conjunction with surgical and/or evaluation procedures in real time. We believe that our technology will enable early detection and more reliable diagnosis of various diseases, such as melanoma, Barrett’s esophagus (a condition caused by chronic acid reflux that can lead to esophageal cancer) and lung cancer. We expect that medical devices using or based on our developed technology can significantly improve long-term patient outcomes and may substantially reduce overall costs for the healthcare system. For more information, please visit http://www.spectralmi.com.
This news announcement contains or may contain certain "forward-looking statements" within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may include, without limitation, statements regarding SMI's plans, objectives, projections, expectations and intentions and other statements identified by words such as "projects", "may", "could", "would", "should", "believes", "expects", "anticipates", "estimates", "intends", "plans" or similar expressions. Such forward-looking statements are subject to significant risks and uncertainties, including those detailed in filings made by Cascade Technologies, Inc., SMI's parent, with the Securities and Exchange Commission. Accordingly we caution our readers that actual results may differ materially from our beliefs or expectations due to economic, business, competitive, market and regulatory factors. We assume no obligation or undertaking to update any forward-looking statements to reflect any changes in expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based. You should, however, review additional disclosures we make in the reports filed with the Securities and Exchange Commission.
Daniel L. Farkas, Ph.D., 310-858-1670